COVID-19 pandemic: SARS-CoV-2 specific vaccines and challenges, protection via BCG trained immunity, and clinical trials

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ABSTRACT

Introduction: The coronavirus disease 2019 (COVID-19) pandemic continues to spread worldwide and vaccination remains the most effective approach to control COVID-19. Currently, at least ten COVID-19 vaccines have been authorized under emergency authorization. However, these vaccines still face many challenges.

Areas covered: This study reviews the concept and mechanisms of trained immunity induced by the Bacille Calmette Guérin (BCG) vaccine and identifies questions that should be answered before the BCG vaccine could be used to combat COVID-19 pandemic. Moreover, we present for the first time the details of current BCG vaccine clinical trials, which are underway in various countries, to assess its effectiveness in combating the COVID-19 pandemic. Finally, we discuss the challenges of COVID-19 vaccines and opportunities for the BCG vaccine. The literature was found by searching the PubMed ( https://pubmed.ncbi.nlm.nih.gov/), Web of Science ( https://www.webofknowledge.com), Embase ( https://www.embase.com), and CNKI ( https://www.cnki.net/) databases. The date was set as the default parameter for each database.

Expert opinion: The advantages of the BCG vaccine can compensate for the shortcomings of other COVID-19 vaccines. If the efficacy of the BCG vaccine against COVID-19 is confirmed by these clinical trials, the BCG vaccine may be essential to resolve the challenges faced by COVID-19 vaccines.

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Defining trained immunity and its role in health and disease

Mihai Netea, Jorge Domínguez-Andrés, Luis Barreiro … (2020)

Immune memory is a defining feature of the acquired immune system, but activation of the innate immune system can also result in enhanced responsiveness to subsequent triggers. This process has been termed ‘trained immunity’, a de facto innate immune memory. Research in the past decade has pointed to the broad benefits of trained immunity for host defence but has also suggested potentially detrimental outcomes in immune-mediated and chronic inflammatory diseases. Here we define ‘trained immunity’ as a biological process and discuss the innate stimuli and the epigenetic and metabolic reprogramming events that shape the induction of trained immunity.

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The COVID-19 vaccine development landscape

Tung Thanh Le, Zacharias Andreadakis, Arun Kumar … (2020)

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Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults

Evan J Anderson, Nadine G Rouphael, Alicia T. Widge … (2020)

Abstract Background Testing of vaccine candidates to prevent infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in an older population is important, since increased incidences of illness and death from coronavirus disease 2019 (Covid-19) have been associated with an older age. Methods We conducted a phase 1, dose-escalation, open-label trial of a messenger RNA vaccine, mRNA-1273, which encodes the stabilized prefusion SARS-CoV-2 spike protein (S-2P) in healthy adults. The trial was expanded to include 40 older adults, who were stratified according to age (56 to 70 years or ≥71 years). All the participants were assigned sequentially to receive two doses of either 25 μg or 100 μg of vaccine administered 28 days apart. Results Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti–S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods. Binding- and neutralizing-antibody responses appeared to be similar to those previously reported among vaccine recipients between the ages of 18 and 55 years and were above the median of a panel of controls who had donated convalescent serum. The vaccine elicited a strong CD4 cytokine response involving type 1 helper T cells. Conclusions In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461.)

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Journal

Journal ID (nlm-ta): Expert Rev Vaccines

Journal ID (iso-abbrev): Expert Rev Vaccines

Title: Expert Review of Vaccines

Publisher: Taylor & Francis

ISSN (Print): 1476-0584

ISSN (Electronic): 1744-8395

Publication date (Electronic, pub): 15 June 2021

Publication date (Electronic, collection): 2021

Pages: 1-24

Affiliations

[a ]Tuberculosis Prevention and Control Key Laboratory/Beijing Key Laboratory of New Techniques of Tuberculosis Diagnosis and Treatment, Institute for Tuberculosis Research, 8th Medical Center, Chinese PLA General Hospital; , Beijing, China

[b ]Faculty of Medicine and Health Technology, Tampere University; , Tampere, Finland

[c ]Fimlab Ltd, Tampere University Hospital; , Tampere, Finland

Author notes

CONTACT Xueqiong Wu xueqiongwu@ 123456139.com Institute for Tuberculosis Research, 8th Medical Center, Chinese PLA General Hospital; , Beijing, 100091, China. Fax: (008610) 80115555 ext. 768415.

Seppo Parkkila seppo.parkkila@ 123456tuni.fi Faculty of Medicine and Health Technology, Tampere University, FI-33014; Fimlab Ltd, Tampere University Hospital, FI-33520; , Tampere, Finland

[#]

These authors have equal contributions to this study.

Author information

Wenping Gong https://orcid.org/0000-0002-0333-890X

Shuyong Wang https://orcid.org/0000-0002-0779-3395

Seppo Parkkila https://orcid.org/0000-0001-7323-8536

Xueqiong Wu https://orcid.org/0000-0001-8894-1929

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Publisher ID: 1938550

DOI: 10.1080/14760584.2021.1938550

PMC ID: 8220438

PubMed ID: 34078215

SO-VID: f586d324-bf7b-45a8-92bf-ce198d2e1834

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This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

COVID-19 pandemic: SARS-CoV-2 specific vaccines and challenges, protection via BCG trained immunity, and clinical trials

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Novel Coronavirus Disease COVID-19

Most cited references 95

Defining trained immunity and its role in health and disease

The COVID-19 vaccine development landscape

Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults

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